INSTRUCTION MANUAL FOR THE

Transcription

1 INSTRUCTION MANUAL FOR THE PAIN-CARE TENS Distributed by: V

2 INDEX Chapter Contents Page 1. General Description Introduction Cautions Warnings Contraindications Adverse Reactions Construction Technical Specifications Replacement Parts Accessories Graphic Symbols Operating Instructions Parameter Controls Attachment of Electrode Lead Wires Lead Wire Maintenance Electrode Options Electrode Placement Tips for Skin Care Application of Re-usable Self Adhesive Electrodes Adjusting the Controls Battery Information Maintenance, Transportation, and Storage Safety-Technical Controls Malfunctions Conformity to Safety Standards Warranty

3 Chapter 1 : GENERAL DESCRIPTION The PAIN-CARE TENS is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reaches the nerves causing pain. The device is provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel. The electronics of the PAIN-CARE TENS create electrical impulses whose Intensity, duration, number per second and modulation may be altered with the controls/switches. Press buttons are very easy to use and the large liquid crystal display showing the exact mode and values of parameters are very convenient for patients Chapter 2 : INTRODUCTION EXPLANATION OF PAIN Pain is a warning system and the body s method of telling us that something is wrong. Pain is important; without it abnormal conditions may go undetected, causing damage or injury to vital parts of our bodies. Even though pain is a necessary warning signal of trauma or malfunction in the body, nature may have gone too far in its design. Aside from its value in diagnosis, long-lasting persistent pain serves no useful purpose. Pain does not begin until coded message travels to the brain where it is decoded, analyzed, and then reacted to. The pain message travels from the injured area along the small nerves leading to the spinal cord. Here the message is switched to different nerves that travel up the spinal cord to the brain. The pain message is then interpreted, referred back and the pain is felt. 2 EXPLANATION OF TENS Transcutaneous Electrical Nerve Stimulation is a non-invasive, drugfree method of controlling pain. TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure any physiological problem; it only helps control the pain. TENS does not work for everyone; however, in most patients it is effective in reducing or eliminating the pain, allowing for a return to normal activity. HOW TENS WORKS There is nothing "magic" about Transcutaneous Electrical Nerve Stimulation (TENS). TENS is intended to be used to relieve pain. The TENS unit sends comfortable impulses through the skin that stimulate the nerve (or nerves) in the treatment area. In many cases, this stimulation will greatly reduce or eliminate the pain sensation the patient feels. Pain relief varies by individual patient, mode selected for therapy, and the type of pain. In many patients, the reduction or elimination of pain lasts longer than the actual period of stimulation (sometimes as much as three to four times longer). In others, pain is only modified while stimulation actually occurs. You may discuss this with your physician or therapist. IMPORTANT SAFETY INFORMATION! Read instruction manual before operation. Be sure to comply with all "CAUTIONS" and "WARNINGS" in the manual. Failure to follow instructions can cause harm to user or device. Chapter 3 : CAUTIONS 1. Federal law (USA) restricts this device to sale by or on the order of a physician. 2. Do not use this device for undiagnosed pain syndromes until consulting a physician. 3. Patients with an implanted electronic device, such as a cardiac pacemaker, implanted defibrillator, or any other metallic or 3

4 electronic device should not undergo TENS treatment without first consulting a doctor. 4. Patients with heart disease, epilepsy, cancer or any other health condition should not undergo TENS treatment without first consulting a physician. 5. Stimulation delivered by this device may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax or across the chest because it may cause a cardiac arrhythmia. 6. Do not place electrodes on the front of the throat as spasm of the Laryngeal and Pharyngeal muscle may occur. Stimulation over the carotid sinus (neck region) may close the airways, make breathing difficult, and may have adverse effects on the heart rhythm or blood pressure. 7. Do not place electrodes on your head or at any sites that may cause the electrical current to flow transcerebrally (through the head). 8. This device should not be used while driving, operating machinery, close to water, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury. 9. Turn the TENS off before applying or removing electrodes. 10. Isolated cases of skin irritation may occur at the site of electrode placement following long term application. If this occurs, discontinue use and consult your physician. 11. If TENS therapy becomes ineffective or unpleasant, stimulation should be discontinued until its use is re-evaluated by a physician 12. Keep this device out of the reach of children. 13. The PAIN-CARE TENS devices have no AP/APG protection. Do not use it in the presence of explosive atmosphere and flammable mixture. Chapter 4: WARNINGS 1. The long-term effects of chronic electrical stimulation are unknown. 2. Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. 4. Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias. 5. Stimulation should not be applied transcerebrally. 6. Stimulation should not be applied over swollen, infected, or in flamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc. 7. Stimulation should not be applied over, or in proximity to, cancerous lesions. Chapter 5: CONTRAINDICATIONS 1. Do not use TENS over the carotid sinus (neck) region. 2. TENS devices can affect the operation of demand type cardiac pacemakers. 3. Do not use the TENS device if you have heart disease without consulting your physician. 4. Do not stimulate on the site that may cause current to flow transcerebrally (through the head). 5. Do not apply TENS for undiagnosed pain syndromes until etiology is established. Chapter 6: ADVERSE REACTIONS On rare occasions skin irritation and burns beneath the electrodes have been reported with the use of electrical stimulators. If irritation occurs, discontinue use and consult your physician. 5

5 Chapter 7 : CONSTRUCTION Chapter 8 : TECHNICAL SPECIFICATIONS The technical specification details of PAIN-CARE TENS are as follows: FRONT 1. On/Off and Amplitude Control Channel A 2. On/Off and Amplitude Control Channel B 3. Blue Backlit LCD 4. Timer Control 5. Program Mode Control 6. Battery Strip 7. Lead Connectors for Channel A & B 8. Amplitude Protective Cover 9. Belt Clip 6 MECHANISM TECHNICAL DESCRIPTION 01. Channel Dual, isolated between channels 02. Pulse Amplitude Adjustable, 0-80 ma peak into 500 ohm load each channel. 03. Wave Form Asymmetrical Bi-Phasic Square Pulse 04. Voltage 0-40V (Load: 500 ohm) 05. Power source One 9 Volt Battery. 06. Size 10cm(L) x 6.3cm(W) x 2.4cm(H) 07. Weight 118.5grams with battery 08. P Mode The pre-set parameters of the 9 programs are as given below. All Programs have a Selectable Treatment Timer. Program Mode Pulse Rate Pulse Width P1 Chronic Modulated Rate 5Hz-125Hz 20µs P2 Acute Constant 80Hz 80µs P3 Burst Burst 80Hz 200µs P4 Neck Constant 80Hz 120µs P5 Shoulder Modulated Width 100Hz µs P6 Back Strength Duration Hz µs P7 Hand/Elbow Modulated Rate 24-80Hz 180µs P8 Knee Mixed Frequency 80/2Hz 250µs P9 Foot/Ankle Modulated Rate 8-80Hz 150µs 09. Timer 15, 30, 45, 60 minutes and C (Continuous) selectable timer for each program. Treatment timer counts down automatically. 10. Low Battery A low battery indicator will show up when Indicator the battery is low. 7

6 11. Operating Temperature:0 ~40 Condition Relative Humidity: 30%~75% Atmosphere Pressure : 700Hpa~1060Hpa 12. Remark There may be up to a +/-10% tolerance of all parameters and +/-20% tolerance of amplitude & voltage. Chapter 9 : REPLACABLE PARTS The replaceable parts and accessories of PAIN-CARE TENS devices are as given below -Except leads, electrodes, battery and battery case cover, please do not try to replace the other parts of a device. PARTS 01 LEAD WIRES 02 ELECTRODES 03 9V BATTERY 04 BELT CLIP 05 BATTERY CASE COVER 06 LEAD CONNECTOR 07 MAIN PCB 08 AMPLITUDE / INTENSITY KNOB 09 LCD COVER 10 INTENSITY CONTROL COVER Chapter 10 : ACCESSORIES Each PAIN-CARE TENS DEVICE comes complete with standard accessories and the standard labels as given below: I. Accessories REF. NO. DESCRIPTION Q'TY 1. KF X40 mm Adhesive Electrodes 4 pieces 2. KE-24 Electrodes Leads 2 pieces 3. 9 V Battery 1 piece 4. Instruction Manual 1 piece 5. Carrying Case 1 piece 8 9

7 II. LABEL The label attached to the back of device contains important information about this device - model name, serial number(started with manufacturing year and week of the device), supply voltage, name of the manufacturer, CE number and classification. Please do not remove. Chapter 11 : GRAPHIC SYMBOLS 1. Degree of Electrical Protection BF 2 Do not insert the plug into AC power supply socket. 3. Timer 4. Low Battery Indicator 5. Increment 6. Decrement 7. Direct Current (DC power source) 8. Consult Instructions for use 9. Manufacturer 10. Serial Number Chapter 12: OPERATING INSTRUCTIONS 1) Insert the 9V battery into the device's battery compartment. Make sure to remove the plastic seal on the 9V battery. Line up the positive and negative terminals on the battery with their corresponding terminals in the device. Make sure that both Inten sity control (ON/OFF Switch) knobs are in the off position. 10 2) Insert the lead wires into the lead wire sockets on top of the device. 3) Open the electrode package. Then insert each lead wire pin into the pig tail of the electrodes 4) Place the electrode on your body as directed by your physician. 5) Slowly turn on the device by rotating the Intensity control (ON/ OFF Switch) knobs. 6) Select the mode and settings as directed by your physician. 7) Slowly increase or decrease the intensity as directed by your physician by rotating the Intensity control (ON/OFF Switch) clock wise to increase, counter clockwise to decrease. 8) After Treatment, Turn the device off by rotating the Intensity control (ON/OFF Switch) counter clockwise to the zero setting. Chapter 13 : PARAMETER CONTROLS PULSE DURATION Wider pulse duration settings will deliver stronger stimulation for any given intensity setting. As mentioned in the Controls section, by using a combination of intensity and pulse duration different nerve fibres are stimulated. The wider pulse duration is needed to recruit motor fibres, whereas the narrow pulse duration is used on the more sensory fibres. The choice of which pulse duration to use is partially dependent upon the Treatment Mode and Protocol selected. PULSE RATE The Pulse Rate (hertz or pulses per second) chosen depends greatly upon the type of electrode placement given to the patient. When using contiguous and dermatome electrode placements (i.e. stimulating directly through the area of pain or localized innnervation), a higher pulse rate (setting greater than 80Hz on the Pulse Rate Control) is required. The patient should not perceive individual 11

8 pulses but rather have the sensation of steady continuous stimulation. When using point treatments, it has been suggested that lower pulse rates be utilized (less than 10Hz). With this setting the patient should be able to perceive individual pulses. When using multiple electrode placement strategies, such as combinations of point and contiguous electrode placements, the higher pulse rates are suggested. Despite the above recommendations, individual patients may require slight variations of the above settings, according to the nature of their condition. TREATMENT MODES (TENS) Normal or Conventional TENS offers the practitioners complete control over all the various treatment parameters of the instrument. Burst Mode is analogous to the Low Rate TENS technique except the low frequency individual pulses are replaced by individual bursts of 7-10 individual pulses. It is thus a combination of Conventional TENS and Low Rate TENS. Modulated Mode attempts to prevent nerve accommodation by continuously cycling the treatment intensity. When using Modulated Mode increase the intensity only when the unit is at the maximum intensity of the modulation cycle. If the intensity is increased during a low intensity period of the modulation cycle, the patient should increase the intensity slowly until the modulation cycle reaches the maximum to insure a true maximum intensity output. Strength-Duration Modulation (SD1 & SD2) consists of alternating modulated amplitude and width so that one parameter is always decreasing while the other is increasing and vice versa. The amplitude decreases from the amplitude control setting and returns to that setting. The width decreases from the width control setting and returns to that setting. INTENSITY Each patient responds differently to different levels of intensity, due to varying degrees of tissue resistance, enervation, skin thickness, etc. Intensity instructions are therefore limited to the following settings: Perception The intensity is increased so that the patient can feel the stimulation, but there is not any muscular contraction. Slight Contraction Intensity is increased to a barely visible muscular contraction that is not strong enough to move a joint. When using low pulse rate settings, this will show as individual twitches. At higher pulse rates there will simply be increased muscle tension. Strong muscular contraction is typically not used in TENS therapy. However, muscular contraction may be useful if the pain involves a cramped or spastic muscle. The TENS can be used as a traditional muscle stimulator in the circumstances to quickly break the spasm. Use a higher pulse rate, wide pulse duration and set the intensity to visible contraction (still within patient tolerance). Twenty or thirty minutes of such a tetanized muscular contraction will generally break the spasm. In all cases, if the patient complains that the stimulation is uncomfortable, reduce intensity and/or cease stimulation. TIME DURATION The onset of pain relief should occur shortly after the intensity setting has been determined. However, in some cases, pain relief may take as long as 30 minutes to achieve, especially when using point electrode placements and slow pulse rates. TENS units are typically operated for long periods of time, with a minimum of 20 ~ 30 minutes and in some post-operation protocols, as long as 36 hours. In general, pain relief will diminish within 30 minutes of the ces- sation of stimulation

9 Chapter 14 : ATTACHMENT OF ELECTRODE LEAD WIRES The wires provided with the system insert into the jack sockets located on top of the device. Holding the insulated portion of the connector, push the plug end of the wire into one of the jacks (see drawing); one or two sets of wires may be used. Chapter 16 : ELECTRODE OPTIONS The electrodes are disposable and should be routinely replaced when they start to lose their adhesive nature. If you are unsure of your electrode adhesive properties, order replacement electrodes. Replacement electrodes should be re-ordered through or on the advice of your physician to ensure proper quality. Follow application procedures outlined in electrode packing, to maintain optimal stimulation and to prevent skin irritation. Chapter 17: ELECTRODE PLACEMENT The placement of electrodes can be one of the most important parameters in achieving success with TENS therapy. Of utmost importance is the willingness of the physician to try the various styles of electrode placement to find which method best fits the needs of the individual patient. After connecting the wires to the stimulator, attach each wire to an electrode. Use care when you plug and unplug the wires. Jerking the wire instead of holding the insulated connector body may cause wire breakage. CAUTION Do not insert the plug of the patient lead wire into any AC power supply socket. Chapter 15: LEAD WIRE MAINTENANCE Clean the wires by wiping with a damp cloth. Coating them lightly with talcum powder will reduce tangling and prolong life. 14 Every patient responds to electrical stimulation differently and their needs may vary from the conventional settings suggested here. If the initial results are not positive, speak to your physician about alternative stimulation settings and/or electrode placements. Once an acceptable placement has been achieved, mark down the electrodes sites and the settings, so the patient can easily continue treatment at home. The unit provides 9 preset programs which can be used for treatment of different pain. The purposes of each program as given below. P1 Chronic Modulated Rate 5Hz-125Hz 20µs P2 Acute Constant 80Hz 80µs P3 Burst Burst 80Hz 200µs P4 Neck Constant 80Hz 120µs P5 Shoulder Modulated Width 100Hz µs P6 Back Strength Duration Hz µs 15

10 P7 Hand/Elbow Modulated Rate 24-80Hz 180µs P8 Knee Mixed Frequency 80/2Hz 250µs P9 Foot/Ankle Modulated Rate 8-80Hz 150µs You may refer to the following placement chart for pain treatment with the PAIN-CARE TENS. Knee Pain-Post Op Degenerative Arthritis-Knee Pain Lower Leg Pain Cervical pain Low Back Pain Wrist Pain Frozen Shoulder Shoulder Pain Sciatica Carpal Tunnel Syndrome 16 Chapter 18: TIPS FOR SKIN CARE To avoid skin irritation, especially if you have sensitive skin, follow these suggestions: 1. Wash the area of skin where you will be placing the electrodes, using mild soap and water before applying electrodes, and after taking them off. Be sure to rinse soap off thoroughly and dry skin well. 2. Excess hair may be clipped with scissors; do not shave stimulation area. 3. Wipe the area with the skin preparation your physician has recommended. Let this dry. Apply electrodes as directed. 4. Many skin problems arise from the "pulling stress" from adhesive patches that are excessively stretched across the skin during application. To prevent this, apply electrodes from centre outward; avoid stretching over the skin. 5. To minimize "pulling stress", tape extra lengths of lead wires to the skin in a loop to prevent tugging on electrodes. 6. When removing electrodes, always remove by pulling in the direction of hair growth. 7. It may be helpful to rub skin lotion on electrode placement area when not wearing electrodes. 8. Never apply electrodes over irritated or broken skin. 17

11 Chapter 19: APPLICATION OF RE-USABLE SELF ADHESIVE ELECTRODES Application 1. Clean and dry the skin at the prescribed area thoroughly with soap and water prior to application of electrodes. 2. Insert the lead wire into the pin connector on the pre-wired electrodes. 3. Remove the electrodes from the protective liner and apply the electrodes firmly to the treatment site. Make sure that the unit is turned off prior to applying the electrodes. Removal 1. Turn off the unit prior to removing the electrodes. 2. Lift at the edge of electrodes and peel; do not pull on the lead wires because it may damage the electrodes. 3. Place the electrodes on the liner and remove the lead wire by twisting and pulling at the same time. Care and Storage 1. Between uses, store the electrodes in the resealed bag in a cool dry place. 2. It may be helpful to improve repeated application by spreading a few drops of cold water over the adhesive and turn the surface up to air dry. Over Saturation with water will reduce the adhesive properties. 2. The electrodes should be discarded and re-ordered from your physician when they are no longer adhering. 3. The electrodes are intended for single patient use only. 4. If irritation occurs, discontinue use and consult your physician. 5. Read the instructions for use of self-adhesive electrodes before application. Chapter 20 : ADJUSTING THE CONTROLS 1. Panel Cover: A lid covers the controls for selecting mode and adjusting settings. Your medical professional may wish to set these controls for you and request that you leave the cover in place 2. Power On/Off Switch and Intensity Controls: If both controls are in the off-position, the device is switched off. By turning the controls clockwise, the appropriate channel is switched on and the indicator of power (CH1 or CH2) will reveal on the LCD. The current strength of the impulses transmitted to the electrodes increases further when the control is turned clockwise. To reduce the current strength or switch the device off, turn the control counter clockwise to the required setting or off-position, respectively. The controls are protected by a cap to avoid unintentional change of intensity. Important 1. Do not apply to broken skin

12 4. Lead Connector Connection of the electrodes is made with the two lead wires. The device must be switched off before connecting the cables. Both intensity controls must be at the Off position. Electrodes must be pressed firmly on the skin. b. Select a Program Select a Preset Program by pressing the PROGRAM control button to select the program desired. You will notice that your Preset Program is selected in two ways. The first is to see the corresponding P# located at the top of your LCD screen will change numbers P1 thru P9. Program Number 5. Program Control There are 9 programs available. The pre-set parameters of the 9 programs are as given below. All Programs have a Selectable Treatment Timer. Please speak to your prescribing physician to which program(s) they would recommend. You will also notice the appearance of a flashing Box or Circle selecting your Preset Program on the LCD screen. Selected Program Program Mode Pulse Rate Pulse Width P1 Chronic Modulated Rate 5Hz-125Hz 120µs P2 Acute Constant 80Hz 80µs P3 Burst Burst 80Hz 200µs P4 Neck Constant 80Hz 120µs P5 Shoulder Modulated Width 100Hz µs P6 Back Strength Duration Hz µs P7 Hand/Elbow Modulated Rate 24-80Hz 180µs P8 Knee Mixed Frequency 80/2Hz 250µs P9 Foot/Ankle Modulated Rate 8-80Hz 150µs 20 The program will begin immediately and after 3 seconds the blue backlit LCD will turn off to save battery power. The program selected will be stored as your default setting once your unit has been turned off. 6. Setting a Treatment Timer The Treatment Timer can be adjusted for any of the 9 Preset Programs. There are five timer settings available: 15, 30, 45, 60 minutes and C (Continuous). The Treatment Timer can be changed at any time before, after or even during a treatment session to better accommodate the user. 21

13 a. Press the TIMER control button to select the time desired. You will notice the treatment timer change on the blue backlit LCD screen. Treatment Timer The treatment timer will begin to count down automatically, except on C (Continuous). b. When treatment time has expired, the unit s output will shut off, but the unit will remain on. The unit will emit a beeping sound for three times as a reminder that your treatment time has expired and you need to turn your unit off. To restart treatment, please turn both On/Off Intensity Control Dials counter clockwise until LCD display has turned off for 3 seconds. HELPFUL REMINDER: To save battery life, the On/Off Intensity Control Dials must be turned completely counter clockwise to the OFF position when unit is not in use. If your LCD screen still shows pictures, your unit is still running and using your battery power. 7. Low Battery Indicator The low battery indicator will show up automatically on the LCD when the battery power is low. The unit may continue to operate for a few more hours depending on the setting and intensity level. 8. Check/Replace the Battery: 22 Over time, in order to ensure the functional safety of TENS, changing the battery is necessary. Over time, in order to ensure the functional safety of TENS, changing the battery is necessary. 1. Make sure that both intensity controls are switched to off position. 2. Slide the battery compartment cover and open. 3. Remove the battery from the compartment. 4. Insert the battery into the compartment. Note the polarity indicated on the battery and in the compartment. 5. Slide the battery compartment cover back on. Chapter 21: BATTERY INFORMATION PRECATIONS 1. Remove battery if equipment is not likely to be used for some time. 2. Please recycle the used battery in accordance with domestic regulation. 3. Do not throw the used battery into fire. If you use rechargeable batteries, please follow the instructions. RECHARGEABLE BATTERIES(NOT INCLUDED): Prior to the use of a new unit, the rechargeable battery should be charged according to the battery manufacturer's instructions. Before using the battery charger, read all instructions and cautionary markings on the battery and in this instruction manual. After being stored for 60 days or more, the batteries may lose their charge. After long periods of storage, batteries should be charged prior to use. 23

14 BATTERY CHARGING (1) Plug the charger into any working 110 or 220/240v mains electrical outlet. The use of any attachment not supplied with the charger may result in the risk of fire, electric shock, or injury to persons. (2) Follow the battery manufacturer's instructions for charging time. (3) After the battery manufacturer's recommended charging time has been completed, unplug the charger and remove the battery. (4) Batteries should always be stored in a fully charged state. To ensure optimum battery performance, follow these guidelines: (a) Although overcharging the batteries for up to 24 hours will not damage them, repeated overcharging may decrease useful battery life. (b) Always store batteries in their charged condition. After a battery has been discharged, recharge it as soon as possible. If the battery is stored more than 60 days, it may need to be recharged. (c) Do not short the terminals of the battery. This will cause the battery to get hot and can cause permanent damage. Avoid storing the batteries in your pocket or purse where the terminals mayaccidentally come into contact with coins, keys or any metal objects. (d) WARNINGS: 1. Do not attempt to charge any other types of batteries in your charger, other than rechargeable batteries made for your charger. Other types of batteries may leak or burst. 2. Do not incinerate the rechargeable battery as it may explode! 24 Chapter 22 : MAINTENANCE, TRANSPORTATION AND STORAGE OF TENS DEVICE 1. Non-flammable cleaning solution is suitable for cleaning the device. Note: Do not smoke or work with open lights (for example, candles, etc.) when working with flammable liquids. 2. Stains and spots can be removed with a cleaning agent. 3. Do not submerge the device in liquids or expose it to large amounts of water. 4. Return the device to the carrying box with sponge foam to en sure that the unit is well-protected before transportation. 5. If the device is not to be used for a long period of time, remove the batteries from the battery compartment (acid may leak from used batteries and damage the device). Put the device and accessories in carrying box and keep it in cool dry place. 6. The packed TENS device should be stored and transported under the temperature range of -20 ~ + 60, relative humidity 20% ~ 95%, atmosphere pressure 500 hpa w 1060 hpa. Chapter 23: SAFETY-TECHNICAL CONTROLS For safety reasons, review the following checklist before using your PAIN-CARE TENS LOW BACK PAIN RELIEF DEVICE. 1. Check the device for external damage. - deformation of the housing. - damaged or defective output sockets. 2. Check the device for defective operating elements. - legibility of inscriptions and labels. - make sure the inscriptions and labels are not distorted. 3. Check the usability of accessories. - patient cable undamaged. - electrodes undamaged. - Battery is not corroded Please consult your distributor if there are any problems with device and accessories. 25

15 Chapter 24 : MALFUNCTIONS Chapter 26 : WARRANTY Should any malfunctions occur while using the PAIN-CARE TENS, check - whether the parameters are set to the appropriate form of therapy. Adjust the control correctly. - whether the cable is correctly connected to the device. The cables should be inserted completely into the sockets. - whether the LCD reveals the menu. If necessary, insert a new battery. - for possible damage to the cable. Change the cable if any damage is detected. * If there is any other problem, please return the device to your distributor. Do not try to repair a defective device. Chapter 25: CONFORMITY TO SAFETY STANDARD The PAIN-CARE TENS devices are in compliance with the following standards: EN : 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests EN :2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 26 All PAIN-CARE TENS models carry a warranty of one year from the date of delivery. The warranty applies to the stimulator only and covers both parts and labour relating thereto. The warranty does not apply to damage resulting from failure to follow the operating instructions, accidents, abuse, alteration or disassembly by unauthorized personnel. Manufacturer: Everyway Medical Instruments Co., Ltd. 3F., No.5, Ln. 155, Sec. 3, Beishen Rd., Shenkeng Dist., New Taipei City 22203, Taiwan (R.O.C.) Representative in the EU: REHAB EUROPA SL SANT GERVASI DE CASSOLES, 96, 3 o 4 a BARCELONA SPAIN Copyright 2015 by Everyway Medical Instruments Co., Ltd. Edition : V1.0 Printed in July